BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3770180 · Received April 24, 2014

    Report

    Report Number
    3004209178-2014-08052
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    April 3, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28 LOT# VA0B716, IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD A POCKET REVISION BECAUSE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PLACED TOO SHALLOW. IT WAS STATED, THE PATIENT HAD DIABETES AND THE INS WAS RUBBING UP AGAINST THEIR CHAIR AND CAUSING SKIN IRRITATION. THE PATIENT REPORTEDLY HAD A ¿SLIGHT¿ INFECTION AT THE POCKET, BUT IT WAS INDICATED THE PATIENT WAS NOT BEING TREATED FOR AN INFECTION. THERE WAS NO PUS AT THE INS SITE WHEN OPENED, BUT ONLY SOME SCAR TISSUE. THE POCKET WAS MOVED DEEPER ON THE SAME SIDE. FOLLOWING THE REVISION, A POWER ON RESET CONDITION WAS PRESENT. ABOUT A WEEK LATER, IT WAS REPORTED THE ISSUE HAD BEEN RESOLVED AND THE BATTERY HAD BEEN REPROGRAMMED. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249148 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention